BMC Medical Ethics

BMC Medical Ethics
BioMed Central
Open Access
Debate
Evidence-based ethics – What it should be and what it shouldn't
Daniel Strech
Address: Institute of Medical Ethics, University of Tübingen, Schleichstraße 8, 72076 Tübingen, Germany
Email: Daniel Strech - [email protected]
Published: 20 October 2008
BMC Medical Ethics 2008, 9:16
doi:10.1186/1472-6939-9-16
Received: 18 September 2008
Accepted: 20 October 2008
This article is available from: http://www.biomedcentral.com/1472-6939/9/16
© 2008 Strech; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: The concept of evidence-based medicine has strongly influenced the appraisal and
application of empirical information in health care decision-making. One principal characteristic of
this concept is the distinction between "evidence" in the sense of high-quality empirical information
on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10
years an increasing number of articles published in international journals have made use of the term
"evidence-based ethics", making a systematic analysis and explication of the term and its applicability
in ethics important.
Discussion: In this article four descriptive and two normative characteristics of the general
concept "evidence-based" are presented and explained systematically. These characteristics are to
then serve as a framework for assessing the methodological and practical challenges of evidencebased ethics as a developing methodology. The superiority of evidence in contrast to other
empirical information has several normative implications such as the legitimization of decisions in
medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent
on which sort of empirical information deserves the label "evidence" and which does not. In
empirical ethics, which relies primarily on interview research and other methods from the social
sciences, we still lack gold standards for assessing the quality of study designs and appraising their
findings.
Conclusion: The use of the term "evidence-based ethics" should be discouraged, unless there is
enough consensus on how to differentiate between high- and low-quality information produced by
empirical ethics. In the meantime, whenever empirical information plays a role, the process of
ethical decision-making should make use of systematic reviews of empirical studies that involve a
critical appraisal and comparative discussion of data.
Background
The concept of "evidence-based ethics", modeled after the
concept of evidence-based medicine, [1] has increasingly
found application in international journals in the past
decade, ranging from a relatively uncritical use of the term
[2-5] to attempts at its explication [6,7] to variously justified repudiations of the term [8,9]. However, so far this
discussion has been lacking a thorough explication of the
term "evidence-based" (EB) and the concept behind it. EB
means more than one might suspect from a translation
one meets with frequently, roughly speaking: "based on
the latest and best available empirical information". For
example, we see a relatively trivial definition of evidencebased ethics along these lines in Pascal Borry et al.: "Ethical decision making must necessarily be based on the use
of the latest and best available medical research findings"
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[6]. Alongside this relatively unspecific explication of the
concept of EB, the discussion so far also lacks an analysis
of the practical problems that threaten to arise on any
non-trivial determination of what evidence-based ethics
might mean.
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per se [11]. And on the other hand, they will shed light on
the relevance of ethical and methodological problems in
assessing the quality of empirical ethics research in practice [12,13].
Discussion
The concept of EB was first used in 1992 in the context of
(clinical) medicine [10]. In the following years the term
was increasingly extended to other areas far removed from
the medical clinic. The most frequently cited characterization of evidence-based medicine (EBM) comes to us from
David Sackett and was published in 1996 in the British
Medical Journal (BMJ) under the title "Evidence-based
medicine. What it is and what it isn't". However, the article failed to do justice to the various normative dimensions inherent in the EB concept, and as of today these
have hardly been explicitly discussed and analyzed in any
conceptual work on EBM. This implicit normativity holds
not just for medicine (EBM) but equally for all those areas
of study that have already been enriched by the EB concept or might be in the future. With the arrival of the EB
concept in medical ethics or bioethics at the very latest our
specialized discussion should explicitly identify these normative aspects and subject them to critical analysis. To
guarantee the responsible employment of a reasonable
and non-trivial reading of the concept, the following will
expand on Sackett's descriptive characterization of EBM
("what it is and what it isn't") and discuss what an evidence-based ethics "should and shouldn't be". In contrast
to the non-trivial interpretation that follows, a trivial reading would be a definition of evidence-based ethics that
amounts to simply taking empirical information into
account in ethical decision-making without specifying
this any further (see above).
To provide a more accurate picture of the challenges and
peculiarities of evidence-based ethics, this article is
divided into three sections. The first is a systematic presentation of central descriptive and normative dimensions
inherent in a non-trivial reading of the EB concept. The
second section will then discuss the ethical problem areas
associated with these normative dimensions using examples from EBM. In a final step these practical problems
will be mapped onto the particularities of applied ethics
(such as the concept of evidence in interview or other
socio-empirical research) in order to clarify the challenges
and limits of evidence-based ethics.
The critical analysis of the particularities of evidencebased ethics is important to ward off the potential misuse
of the EB concept in medical ethics in a timely manner.
But beyond this the results of this analysis are also significant for two further debates within modern bioethics. On
the one hand, the results help to clarify more precisely
how ethics conceives itself in its relation to empirical data
Descriptive dimensions of "evidence-based"
In Sackett's definition, EBM is described in a more general
version as follows:
"Evidence-based medicine is the conscientious,
explicit and judicious use of current best evidence in
making decisions about the medical care of individual
patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research." [1] p.
71
In the context of evidence-based ethics it is not the specification of EB for medicine that interests us so much but
the characterization of what evidence or EB means in general. Textbooks and other writings on EBM provide us
with further specifications of the content and the scope of
the EB concept [14]. The following derives several characteristic descriptive dimensions of the concept from these
specifications, and supplements them with the normative
dimensions not explicitly discussed by Sackett and other
authors (see figure 1).
Externality
In medicine and medical ethics we encounter empirical
information in various forms, such as quantitative and
qualitative indications of the benefit and harm of medical
measures, reports of the number of organ donations, or
on the level of satisfaction with clinical ethics consultation. This empirical information can be divided into the
information that one has garnered in the course of one's
life and professional experience (thus internally) and
information that others have garnered (externally) in
studies. As emphasized in the quotation from Sackett, the
concept of evidence in EB stands for externally generated
empirical information.
Complementarity
External evidence alone cannot influence any decisions –
it always exists in a complementary relation to contextspecific framing conditions, ethical principles and other
decision-theoretical elements. Furthermore, typically various pieces of empirical information play a role in decisions. In the medical context, besides the internal and
external information on the benefit of a measure, the individual or group-specific preferences of the patients in particular should also be taken into consideration.
Complementary elements in ethical decisions also
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Figure 1 and normative dimensions of the concept "evidence-based"
Descriptive
Descriptive and normative dimensions of the concept "evidence-based".
include context-sensitive ethical principles or norms (see
below).
Gradualness and context-specificity
On a reasonable, non-trivial reading evidence (which is
external) cannot be simply equated with empirical information per se. Not all available empirical information on
a certain question counts directly as evidence according to
the EB concept. Empirical information has to hold up
under critical appraisal, a sort of qualifying exam, in order
to be accepted into the higher class of evidence. Sackett
writes:
"Because the randomised trial, and especially the systematic review of several randomised trials, is so much
more likely to inform us and so much less likely to
mislead us, it has become the 'gold standard' for judging whether a treatment does more good than harm.
[...]And if no randomised trial has been carried out for
our patient's predicament, we must follow the trail to
the next best external evidence and work from there."
[1] p. 72
According to this conception of EB only the available
information that is sufficiently reliable (as determined by
context) and demonstrates internal and external validity
can be called evidence. This point is of central importance
– in principle each question prompts a new decision
about which information is to be considered evidence.
The reliability determines how exactly a study measures a
certain characteristic. There are various measures for
quantifying the reliability of a test that cannot be individually discussed here [15]. The criterion of validity is
divided into internal and external validity. Internal validity pertains to the credibility of the results within the
study. In view of the diverse possible sources of systematic
bias and the influence of chance, the EB concept demands
that we only consider the results of those studies that
reduce the risk of systematic bias and the influence of
chance as much as possible. The external validity, on the
other hand, describes the validity of the results outside the
population considered by the study. Thus external validity
is often used as a synonym for generalizability.
Hence there is a gradual relationship between empirical
information per se and the empirical information that the
EB concept considers evidence. In the field of medicine,
for example, this often leads to a situation where, despite
the availability of results from studies on the benefit of a
certain medical procedure, its efficacy or effectiveness is
not considered evidence-based, since the quality of the
studies (their internal validity) or the generalizability of
their results (external validity) have not been judged satisfactory. Here we have to keep in mind that medical and
statistical experts often arrive at different answers to the
central question: is the effectiveness of this specific medical intervention evidence-based or not? Examples of this
include the controversy surrounding the early detection of
breast cancer with mammography screening [16] or medication for the treatment of Alzheimer's disease
(cholinesterase inhibitors) [17]. How to best approach
this situation of a dispute among experts is at present an
unresolved problem in EBM and medical ethics that has
generated astonishingly little discussion [18]. This last
problem in particular is closely related with the normative
dimensions of the EB concept discussed below.
Normative dimensions of "evidence-based"
Legitimation of action
The EB concept includes the normative dimension of the
legitimation of action. Whenever empirical information
plays a role in decision-making (be it medical, ethical, or
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health policy decisions), according to the EB concept the
information should be given preference that fits or best
fits the criteria of evidence (see above). Empirical information that reaches the highest EB status should be
trusted more in action-oriented decisions than empirical
information that does not satisfy the criteria of evidence.
The legitimation of action that this involves does not arise
on its own, nor are we dealing with a naturalistic fallacy.
Rather the typical case is that previous specification of
principles [19] and other deliberative processes determined what empirical information is needed to arrive at a
rational decision through ethical principles. Thus in medical and ethical decision-making, for example, the benefit
of a medical procedure plays a central role. Very often it is
not clear whether a procedure produces significant and
clinically relevant benefits, despite the availability of studies. However, should it be determined at a later time with
newer and better studies that the benefit of the procedure
is evidence-based, this will count strongly in favor of legitimating the use of the procedure as well as its funding by
health insurance. This situation would only present us
with a naturalistic fallacy if the significance of medical
benefit for the decision-making process were not determined in advance and thus was already posited as a normative judgment.
Quality assessment
The decision as to what should be considered evidence is
based on the quality of the underlying studies, i.e. their
reliability and validity. Only the empirical information
supported by a context-sensitive study of appropriate
quality is to be considered evidence. But who can or
should decide, using which criteria, whether the quality
standards have been met or not? In actual medical practice
and in empirical ethics we will have to continually lower
the bar, since the perfect study without any susceptibility
for systematic bias does not exist. This holds for experimental studies that generate the greater share of evidence
in medicine and even more for qualitative studies and survey research that, according to the overview taken by Borry
et al., represent the most common form of empirical
research in ethics [20]. In many cases a high internal validity and a high external validity are mutually exclusive. So
where should the optimal quality of study be pegged at?
How far can the optimal quality be removed from the
maximum? These decisions in assessing the quality of
empirical information and their underlying studies imply
various value judgments concerning the relevance of outcome parameters to the patient, the weighing of costs and
benefits, the tolerance of uncertainty due to suboptimal
study quality, and others [18]. With regard to the tolerance of uncertainty, for instance, we must acknowledge
that every choice in this regard requires balancing the
uncertainty of being wrong in our inferences about study
quality with the probability of missing important information from studies of suboptimal quality. The answer to
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how much uncertainty in study quality we are willing to
accept ought to be dependent on the context (e.g., severity
of disease, existence of alternatives) and on the preferences and values of the particular stakeholder population
to which the empirical information will be applied.
Because there is no "one size fits all" approach for determining how much uncertainty should be tolerated in
designing clinical studies or survey research, it becomes
important for users of empirical data to be given more
information about the investigators tolerance of uncertainty and their rationale for their choices in a given circumstance. A more thorough analysis of these various
value judgments is beyond the scope of this paper. For a
systematic analysis of these value judgments, see [18,21].
Evidence and consensus
In the following the descriptive and normative dimensions of the EB concept will serve as a framework for a critical analysis of the associated challenges in general and for
an evidence-based ethics in particular. It is important to
keep in mind that the basic idea underlying the EB concept deserves our strong endorsement from an ethical perspective. When empirical information plays a role in
decision-making, it should be weighted differently
depending on its quality. However, from an ethical perspective the application of the EB concept becomes problematic when it is used uncritically or misused in order to
legitimate actions. When a group of experts determines
that the benefit of a certain medical procedure is evidencebased, this has a strong legitimating effect on certain
actions at present. Doctors could come into conflict with
their liability in civil law if they do not take evidencebased action, and insurance companies find it much
harder to justify themselves if they wish to not fund evidence-based procedures. Yet before we can determine
which empirical information deserves the "evidencebased" seal of quality, we first need context-specific standards for the optimal or at least sufficient internal and
external validity. The search for consensus on such standards runs into significant problems in the case of internal
validity, and the question of external validity only exacerbates them. Within EBM, for example, it is a matter of contentious debate whether the demands for internal validity
are met by the use of a certain experimental study design
(randomized controlled trials) or whether further aspects
have to be considered (e.g. the dropout rate of the study
participants) [22]. With the qualitative and quantitative
empirical studies in medical ethics we can expect analogous controversies concerning the optimal methods of
sampling, the evaluation of survey questions or the best
ways to carry out interviews and analyze and interpret the
results [23].
Depending on how strict we make the criteria for the
needed empirical information to count as evidence-based,
we will come to different conclusions about the underlyPage 4 of 9
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ing question (In EBM the question at issue is generally the
quantitative and qualitative extent of benefit and harm
from certain medical interventions. In empirical ethics
(mostly interview research) the question is to determine
majority views or to analyze opinions and attitudes). The
selection and concretization of these criteria always
involves normative judgments (see above). This would
not in itself be so problematic, were it not for the fact that
in practice we see various decision-makers frequently
working with different criteria of assessment – hence the
need to make these normative judgments transparent
[18]. If they are not made sufficiently transparent, as we
unfortunately see most of the time in practice, there is an
ethically problematic latitude in the EB concept that
allows for manipulation, namely: the exploitation of the
EB concept for the dimension of legitimation of action even
though there is no sufficient consensus regarding the relevant normative values posited in the quality assessment
dimension. In other words: decisions can then be legitimated under the "evidence-based" seal of approval even
though there is no consensus concerning what should
count as evidence and what not in the particular context.
Of course, this also works the other way round: The EB
concept can also be exploited to argue against certain
actions, e.g. the clinical use or coverage of medical interventions.
These considerations should have made it clear that the
often criticized dimension of legitimation of action is not,
in itself, the real ethical problem with the EB concept.
Quite the contrary, it represents the reasonable and yet
crucial ethical demand that medical and ethical decisions
should be based on reliable and valid information, not on
whatever information might have been gathered together
arbitrarily or that might otherwise be susceptible to bias.
Rather, for EBM and evidence-based ethics the particular
ethical and methodological challenges are to analyze the
normative judgments for distinguishing evidence from
empirical information per se and account for them in
practice with sufficient transparency. Before we can critically analyze this normativity implicit in the dimension of
quality assessment of empirical information we need to
have sufficient transparency about these value judgments
in the first place.
What an evidence-based ethics should be
In order to analyze the particularities of an evidence-based
ethics, the following will begin by outlining a conception
of the relation between normative and empirically
descriptive statements. The relation between norms and
facts has become an occasion of controversial debate in
the past years, with the notable key terms including the
"empirical turn in bioethics" [13] and the "social science
critique of bioethics" [11]. This discussion cannot be recapitulated in any detail here. In a nutshell, as it relates to
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applied ethics, we could paraphrase Kant: thoughts (ethical principles, norms) without content (empirical information, evidence) are empty, intuitions (empirical
information, evidence) without concepts (ethical principles, norms) are blind. [24] p. 130 (Translation by the
author (DS). The parenthetical text is the author's addition). Thus normative and empirical statements should
not be seen as competing for justificatory authority in ethical decisions, and hence there is not necessarily any danger of running into the naturalistic fallacy (see above).
Rather, we should see the relation between norms and
facts in the decision-making process as complementary.
Each is necessary but not by itself sufficient for decisionmaking in applied ethics. The role of both ethical principles and empirical information is shown schematically in
figure 2.
The classical principles of medical ethics [25] need to be
given more specific content in actual cases – the principles
of beneficence and non-harm, for example, only take on
real concrete form once the dimensions of benefit and
harm have a clear and specific content. To assess the justness of an action we need empirical data on distribution
or on the possibilities of access to the health care system.
Patient autonomy in turn is tied to the availability of
patient preferences (individual or group-specific), which
also have to be ascertained empirically.
Besides this interactional scheme, the figure also shows
the characteristic normative dimensions of an evidencebased ethics. In the processes of quality assessment (A)
and relevance assessment (B) typically there is some available external empirical information that does not reach
the status of evidence. We could picture these processes as
a sieve that sorts out some empirical information and
leaves behind only external evidence. Only after a sufficiently critical assessment of the internal and external
validity of the available empirical information are we justified in speaking of external evidence as the foundation
for the specification of ethical principles. In principle we
could conceive a similar process for one's own (empirical)
experiences. In an ethical dilemma one could classify
one's previous experiences as potentially distorted (quality assessment) or as not relevant for the case at hand (relevance assessment). Those experiences considered
adequate and relevant could be termed internal evidence,
in analogy to external evidence. However, since this
assessment process cannot be examined intersubjectively
and remains of necessity purely subjective, this internal
evidence cannot be counted as evidence in the sense of
evidence-based ethics (see the dimension of externality).
According to the interactional scheme in figure 2, a reflective and/or deliberative element has to precede the decision at the end in evidence-based ethics as well. The
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Prima facie principles
Respect of
autonomy
Beneficence
Non-maleficence
Justice
Ethical dilemma
Individual (empirical) experiences
External empirical information
(A) Quality assessment (validity, reliability)
(B) Relevance assessment
Internal evidence
External Evidence
Specified principles
Specified patient
preferences
Quality, relevance
and extent of
medical benefits
Quality, relevance
and extent of
medical harms
Access to care,
societal costs
Reflective equilibrium (trade-offs)
(Evidence based) ethical decision making
Figure
The
process
2 of decision-making in an evidence-based ethics
The process of decision-making in an evidence-based ethics.
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weighing of specified principles against each other is basically no different from what coherence theories of ethics
call reflective equilibrium [25,26]. In reflective equilibrium
the ethical and conceptual aspects have to be weighed
against each other together with empirical information.
This reflective equilibrium is susceptible to bias when
methodologically bad and hence false or potentially misleading empirical information is taken into consideration.
An evidence-based ethics only makes use of the best
empirical information available in the case at hand in
reflective equilibrium and sets (context-specific) minimal
standards for the quality of empirical information that
deserves the label of external evidence.
The limits of an evidence-based ethics in practice
Having presented a rational and non-trivial reading of evidence-based ethics as a theoretical conception, this paper
is now particularly concerned to identify the limits of evidence-based ethics in practice and the risks that go along
with it. Whether the idealized conception of an evidencebased ethics presented in the previous section can be realized in the conditions of actual practice depends on several factors.
Before we can speak of evidence-based ethical decisions in
practice, we have to demonstrate the extent to which we
can assume a consensus on the specific use of the concept
of evidence. To avoid misuse of the dimension of action
legitimation (see above) or at least constrain it within certain limits we need a transparent justification for the use
of the EB concept. This justification is not found in the
articles cited at the beginning of this paper that use the
concept of evidence-based ethics [2-5].
Another practical problem facing us is how to provide the
EB concept with specific content depending on the methods used in studies. For example, the results of psychometric studies to determine the decision-making
competence of patients with dementia could be relevant
to research ethics. In the ethical discussion of advance
health care directives, in turn, the results of quantitative
and/or qualitative interview studies to determine patient
preferences can be relevant. Various studies are available
for both of these problem areas that can be expected to
vary greatly in their validity and reliability [27,28]. Which
of these studies should be considered evidence according
to the assessment steps (A) and (B) in figure 2? We need
objective criteria or adequate procedures for reaching consensus in order to justify why certain ethically relevant
empirical information does or does not deserve the status
of evidence. Of course this condition can only be realized
if objective criteria are available to distinguish evidence
from other ethically relevant empirical information. Here
we still find great obstacles in practice, which again can be
characterized by comparison to the practice of EBM. As
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already discussed, there is a contentious discussion within
EBM as well concerning what one "may" or "should" with
justification call "evidence-based". We can distinguish
between two different problematic situations in EBM
practice. Firstly, it is often a matter of contention whether
certain medical decisions or recommendations are at all
evidence-based or not, where some people consider the
criteria for EBM to be satisfied and others not (Goodman). An example is the discussion of the medical benefit
of Alzheimer's treatments. Several studies taking a general
view of the situation conclude that their benefit is evidence-based [29,30], while others point to methodological flaws in the studies and take a very critical stance
towards the use of the EB concept in this context [17,31].
A second example can be found in the discussion of the
benefit of mammography screening for early detection of
breast cancer. Again several studies speak in favor of an
evidential basis of its benefit [32] while others come to the
opposite conclusion and argue that to the contrary, the
preponderance of harm over benefit is evidence-based
[33]. The normative judgments mentioned above that go
into the assessment of the quality of studies play a decisive
role in these differences. This presents modern medicine
as well as applied ethics with a practical problem of ethics
and decision theory.
What problems does all this imply for an evidence-based
ethics? As long as the relevant evidence of evidence-based
ethics relates to the beneficial and harmful results of medical interventions, we can assume similar problems to
those described in medicine. However, a more in-depth
look at the practice of evidence-based ethics will have to
consider the fact that most studies grouped under the
heading "empirical ethics" use non-experimental methods taken from the social sciences. Quantitative and qualitative interview and questionnaire studies are conducted
quite frequently in the course of projects on applied ethics
[20,28]. These research methods can generate valuable
empirical information for ethics. The goal of such investigations could be to determine patient preferences, the values of certain stakeholders in the field of health care, or
attitudes and experiences with certain informed-consent
procedures. Here as well studies can demonstrate better or
worse methodological quality (internal validity, reliability) and can be more or less generalizable (external validity). Yet the discussion of when we are justified in calling
the results of these types of studies evidence is still in its
very beginning stages. The assessment of the internal and
external validity of qualitative interview research in particular is the subject of much controversy [23,34]. This discussion also gives rise to the question of whether validity
and reliability criteria as they have traditionally been used
can even be applied to these types of studies [35]. But for
quantitative research that uses questionnaires we also still
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lack a generally accepted gold standard of quality assessment [36,37].
These problems do not speak against carrying out these
sorts of studies or using the results in making ethical decisions. They do, however, clearly point to the practical
problems that arise in using the concept of evidencebased ethics. Without the appropriate tools to distinguish
better and worse empirical studies, the EB concept cannot
find any application in ethics.
Conclusion
A rational, non-trivial reading of the EB concept has to be
distinguished from empirical information per se. Because
of its normative dimension of action legitimation, we
need a transparent and rational justification of the context-specific use of the EB concept in medicine as well as
in ethics. This is to be ensured through an explicit discussion within each field as to the validity and relevance of
the empirical information to be considered evidence.
The relation between norms and facts was described as
complementary in applied ethics. Empirical information
per se is necessary to give concrete and context-specific
reality to ethical principles. Yet neither empirical information nor ethical principles are sufficient for an ethical decision-making process in the context of medical ethics. The
necessary interdependence of norms and facts is not sufficient to fully characterize the concept of evidence-based
ethics. A rational, non-trivial reading of evidence-based
ethics is characterized by a well-justified, context-specific
differentiation between empirical information per se and
the more qualitatively valuable evidence that has greater
weight in the legitimation of action.
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information and hence no transparent discussion of the
internal and external quality of the empirical information.
A middle course between the evidence-based ethics that is
not currently possible and a merely superficial treatment
of empirical information is an ethics that calls for the critical appraisal of empirical information in the context of totality
of data. Here, in a first step, systematic reviews aim to identify all studies that focused on research questions relevant
for a certain ethical dilemma [38]. In a second step the
review need to critically appraise, compare and discuss the
empirical findings. The critical appraisal includes the following three aspects: (i) the validity of the data, (ii) the
transferability of the data to the context under discussion
and (iii) the relevance of the results for the decisions or
recommendations at issue. In the discussion one has to
interpret and qualitatively compare findings of different
studies that investigated similar research questions.
A critical appraisal of empirical ethics can only be implemented in practice if the question of what comprises better or worse empirical information in ethics can be
intersubjectively discussed and negotiated. This article has
presented various difficulties that require further pragmatic discussion for their solution. Furthering this process
of clarification, which has been neglected so far, is at least
as important as the current intensive discussion about the
relation between ethics and empirical information.
Competing interests
The author declares that he has no competing interests.
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Yet so long as no criteria or standards with sufficient general acceptance are available to justify a transparent characterization of empirical information as evidence, we
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